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1mg twice daily for eight weeks after a one week dose escalation phase.

Detailed Description:

Parkinson disease (PD) is a clinical entity characterized by bradykinesia, rigidity, tremor, and postural instability. Current treatments primarily focus on replacement of dopamine to compensate for the degeneration of the substantia nigra pars compacta dopaminergic neuronal population. Though dopamine treats many of the motor symptoms of PD, postural instability (which often leads to falls) typically is least responsive to therapy. More recently, the degeneration of the cholinergic system arising from the pedunculopontine nucleus (PPN) in the brainstem has been implicated in gait dysfunction in PD. Striatal cholinergic inputs are supplied from the PPN both via the intralaminar complex of the thalamus and through direct inputs. The primary subtypes of cholinergic receptors present in the striatum are nicotinic and include α4β2, α6β2, and α7 receptors. Varenicline (Chantix) is a novel partial α4β2 agonist and full α7 agonist developed as an aid for smoking cessation and has been shown in initial studies to improve imbalance in patients with inherited spinocerebellar ataxia. The unique method of action of varenicline may make it an ideal drug for the treatment of balance impairment in PD.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

40 Years to 90 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects will be diagnosed with Parkinson Disease (PD) by the UK Brain Bank criteria.

Subjects will have to be at least stage 2 on the Hoehn and Yahr staging system of PD and have a history of at least 1 fall or near fall in the last 6 months

Subjects must have a stable medication regimen.

All subjects will be over the age of 40 in an attempt to exclude inherited forms of parkinsonism.

Women of childbearing potential who are pregnant at the time of screening or who will not use adequate protection during participation of the study.

Allergy/sensitivity to the drug or its formulations.

Concurrent participation in another clinical study.

Active substance or tobacco use or dependence.

Moderate or severe chronic obstructive pulmonary disease.

Serious illness (requiring systemic treatment/or hospitalization) until the subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 60 days prior to study entry.

Inability or unwillingness of the subject or legal guardian/representative to give written informed consent.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341080